FDA.reportPublic FDA data

Olay Regenerist Mineral Sunscreen Hydrating Moisturizer Broad Spectrum SPF 15

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2023-06-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:30:07

Label at a glance#

ProductOlay Regenerist Mineral Sunscreen Hydrating Moisturizer Broad Spectrum SPF 15
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

apply liberally 15 minutes before sun exposure reapply at least every 2 hours use water resistant sunscreen if swimming or sweating Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in sun, especially from 1...

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

ZINC OXIDE 9.7%

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use water resistant sunscreen if swimming or sweating
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, caprylic/capric triglyceride, isohexadecane, glycerin, steareth-21, polyacrylamide, stearyl alcohol, polyhydroxystearic acid, C13-14 isoparaffin, behenyl alcohol, triethoxycaprylylsilane, hydroxyacetophenone, phenoxyethanol, cetyl alcohol, laureth-7, steareth-2, disodium EDTA, niacinamide, tocopheryl acetate, palmitoyl pentapeptide-4

SPL UNCLASSIFIED SECTION

Distr. by PROCTER & GAMBLE

CINCINNATI, OH 45202

Questions or comments?

OTC - QUESTIONS SECTION

Questions
1-800-285-5170

PRINCIPAL DISPLAY PANEL - 50 mL carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Olay Regenerist

MINERAL SUNSCREEN

HYDRATING

MOISTURIZER

WITH SUNSCREEN

ZINC OXIDE

BROAD SPECTRUM

SPF 15

1.7 FL OZ (50 mL)

OlayOlay

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-48969423-489-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOHEXADECANE918X1OUF1EIACT
LAURETH-7Z95S6G8201IACT
NIACINAMIDE25X51I8RD4IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
TOCOPHEROLR0ZB2556P8IACT
DOCOSANOL9G1OE216XYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ZINC OXIDESOI2LOH54ZACTIB
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PALMITOYL PENTAPEPTIDE-4KK181SM5JGIACT
STEARETH-2V56DFE46J5IACT
C13-14 ISOPARAFFINE4F12ROE70IACT
STEARYL ALCOHOL2KR89I4H1YIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
EDETATE DISODIUM7FLD91C86KIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYACRYLAMIDE (1300000 MW)SC5Y4X78TGIACT
STEARETH-2153J3F32P58IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fdf17ffa-6817-2809-e053-6394a90a5b6efdf17ffa-6818-2809-e053-6394a90a5b6e2023-06-12WarningsExact identifier
spl id: fdf17ffa-6817-2809-e053-6394a90a5b6e
spl set id: fdf17ffa-6818-2809-e053-6394a90a5b6e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.